[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624479":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Guangdong Provincial People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HBOT group","EXPERIMENTAL","hyperbaric oxygen intervention：Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)",[13],"Device: Hyperbaric oxygen treatment",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","Standard care",[18],"Other: Standard Care (in control arm)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Hyperbaric oxygen treatment","Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)",[9],null,{"type":6,"name":27,"description":16,"armGroupLabels":28,"otherNames":25},"Standard Care (in control arm)",[15],[30],{"name":31,"affiliation":5,"role":32},"Kun Wang","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Kun Wang, PhD","CONTACT","+8615989223200","gzwangkun@126.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Yingcong Lin, Master of Medicine","+8618666885689","18666885689@163.com",[44],{"facility":5,"status":25,"city":45,"state":46,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Guangzhou","Guangdong","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.25,23.11667,{"lat":53,"lon":52},[56,59],{"name":57,"role":36,"phone":58,"phoneExt":25,"email":42},"Yingcong Lin, master of medicine","+86 18666885689",{"name":35,"role":36,"phone":60,"phoneExt":25,"email":38},"+8613922118086",{"type":32,"investigatorFullName":31,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Professor","100624479","phase-2-efficacy-and-safety-of-hyperbaric-oxygen-therapy-in-improving-nab-paclitaxel-induced-peripheral-neuropathy-100624479",false,"NCT07410169","Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy","Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. aged ≥ 18 years and ≤ 75 years, female\n2. early-stage breast cancer or locally advanced breast cancer\n3. Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel\n4. The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4\u002F10.\n5. The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n1. Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.\n2. Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.\n3. Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).\n4. Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.\n5. Karnofsky Performance Status score \\\u003C 80\n6. Patients with any other conditions that the investigator deems unsuitable for participation in the study.","FEMALE","18 Years","75 Years",{"count":74,"type":75},160,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.",[82,83,84],"Breast Cancer","CIPN - Chemotherapy-Induced Peripheral Neuropathy","Paclitaxel-induced Peripheral Neuropathy",[82,86,87],"paclitaxel-Induced Peripheral Neuropathy","Hyperbaric Oxygen Therapy","NOT_YET_RECRUITING","2026-02-07",{"date":91,"type":92},"2026-02-13","ACTUAL",{"date":94,"type":75},"2026-01-31",{"date":96,"type":75},"2027-12-31",{"name":5,"class":6},1]